NCT05417178

Brief Summary

This is a study to validate myStrength's macropersonalization algorithm. Specifically, the study seeks to answer: Does myStrength's macropersonalization algorithm match what a clinician would offer as a diagnosis following an expert assessment? Participants will be treatment-seeking adults, ages 18 to 65, recruited from an evidence-based group psychotherapy practice. Participants will be asked to complete myStrength onboarding and a clinician-conducted initial assessment. Inter-rater reliability will be assessed to determine the consistency between myStrength and clinician in primary focus area of digital program.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

May 22, 2022

Last Update Submit

June 9, 2022

Conditions

Keywords

SleepDigital Therapy

Outcome Measures

Primary Outcomes (1)

  • Inter-rater reliability on primary focus area

    Inter-rater reliability between myStrength macropersonalization engine and expert clinical recommendation for an individual's primary focus

    Upon completion of initial assessments by subject and clinician within 30 days of signing informed consent.

Interventions

An onboarding process that utilizes the PHQ-9, GAD-7, and WHO-5 that leads to a user of the digital program's clinical focus and primary, secondary, and tertiary intervention recommendations.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be individuals seeking initial evaluation and treatment at the Pacific Anxiety Group.

You may qualify if:

  • Aged 18 to 85, inclusive
  • Able to read, write, and speak in English
  • Has access to the Internet to complete study procedures
  • Currently engaged in therapy or has schedule an initial appointment with the Pacific Anxiety Group

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pacific Anxiety Group

Menlo Park, California, 94025, United States

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety DisordersWounds and Injuries

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Bobbie James, MStat

    Teladoc Health

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2022

First Posted

June 14, 2022

Study Start

May 1, 2022

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

June 14, 2022

Record last verified: 2022-06

Locations